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Found 41 results
510(k) Data Aggregation
(163 days)
GM Helix Implant:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The GM Helix Implant System with 3.75 and 4.0 diameter and 18 mm length are indicated for surgical installation in the pterygoid region (upper jaw), for multiple unit restorations, when combined with 45° angulation abutment, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Implants in the pterygoid indication should be used in splinted applications that utilize at least two implants.
GM Helix LG Implant:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Neodent GM Helix LG implants can be placed bicortically in cases of reduced bone density. The Neodent GM Helix LG implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. The GM Helix LG Implant System is indicated for surgical installation in the pterygoid region (upper jaw), for multiple unit restorations, when combined with 45° angulation abutment, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.
GM Mini Conical Abutment 45°:
The Mini Conical Abutments 45° and 60° are indicated for use with Zygomatic Implants, in cases of severe jaw resorption, in order to restore patient aesthetics and chewing function. The Mini Conical Abutments 45° are also indicated for use with Pterygoid implants in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. The Mini Conical Abutments may be used with single stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
GM Mini Conical Abutment 45° Slim:
The Mini Conical Abutments 45° and 52° are indicated for surgical procedures in Zygomatic bones, making possible the rehabilitation with screw-retained abutments over the implant, thus restoring the chewing function. The Mini Conical Abutments 45° are also indicated for use with Pterygoid implants in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. The Mini Conical Abutments may be used in one- or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load. Multiple rehabilitations may be splinted rigidly.
This premarket notification seeks to expand the indications for use of the subject implants and abutments, in order to include anchorage in the pterygoid region. These devices were previously cleared under 510(k) K163194, K190958, K190718 and K232099 for the functional and esthetic oral rehabilitation of the upper or lower jaw in edentulous or partially edentulous patients. The proposed implants and abutments remain with the same design and features already cleared in the original submission.
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(217 days)
Atlantis Abutment & Atlantis Abutment Milling
The Atlantis Abutment and Atlantis Abutment Milling are intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The Atlantis Abutment screw is intended to secure the Atlantis Abutment to the endosseous implant.
Atlantis Crown Abutment
The Atlantis Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The Atlantis Abutment screw is intended to secure the Atlantis Crown Abutment to the endosseous implant.
Atlantis Conus Abutment
The Atlantis Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is an attachment-retained by friction fit to the abutment. The Atlantis Abutment screw is intended to secure the Atlantis Conus Abutment to the endosseous implant.
Atlantis Healing Abutment
The Atlantis Healing Abutment is intended for use with an endosseous implant for temporary use during soft tissue healing after one-stage or two-stage surgeries. The Atlantis Abutment screw is intended to secure the Atlantis Healing Abutment to the endosseous implant.
Implant Manufacturer: Institut Straumann
Implant System: Straumann BLX
Implant Diameter (in mm): 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5
Abutment Platform Diameter (in mm): 2.69
Implant System: Neodent GM
Implant Diameter (in mm): 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0
Abutment Platform Diameter (in mm): 3.0
The Atlantis® Abutments in Titanium are patient-specific dental abutments that are intended for attachment to dental implants in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The design of the Atlantis® Abutments in Titanium is derived from patient dental models and is completed by Dentsply Sirona using computer-assisted design (CAD) technology according to the clinician's prescription. The final CAD design of the Atlantis® Abutment in Titanium is fabricated using computer-assisted manufacturing (CAM) to produce a customized, patient-specific device. Design and fabrication of the Atlantis® Abutment in Titanium is completed in internal Dentsply Sirona manufacturing facilities.
Alternatively, the CAD design, according to the clinician's prescription, can be performed by a laboratory or clinician in an FDA cleared abutment design software (3Shape Abutment Designer Software, K151455) within the design envelope of the Atlantis® Abutments which is codified in the validated and locked design library of the cleared software. Fabrication of the Atlantis® Abutment is then completed in internal Dentsply Sirona manufacturing facilities.
The Atlantis® Abutment in Titanium serves as a connection of the prosthetic construction and the endosseous implant. The lower part of the abutment is designed to fit with the specific implant geometry it is compatible, and the upper part design is according to the patient's specific anatomy. The Atlantis® Abutment, including the Conus and Healing abutments further described below, are available in Titanium or Gold-shaded (titanium nitride layer applied using PVD (Physical Vapor Deposition)) Titanium. The Crown Abutment which is another Atlantis® Abutment in Titanium, is only available in Titanium.
The Atlantis® Abutment design envelope became the basis for the other more specific designs that make up the Atlantis® Abutments in Titanium. The Atlantis® Abutment is intended for use with an endosseous implant and for single tooth restoration.
The Atlantis® Crown Abutment in Titanium is also a custom fabricated abutment using the same internal CAD/CAM technology. The Atlantis® Crown Abutment in Titanium incorporates a design that is a combination of an abutment and an anatomically accurate crown to constitute the final finished device. It functions as a substructure that also serves as the final abutment, in a partially or completely edentulous patient.
The Atlantis® Conus Abutment supports a removable prosthesis (bridges and overdentures) which is retained by friction fit to the abutment. The abutment connects to the prosthesis via caps embedded in the prosthesis.
The Atlantis® Healing Abutment is used with the compatible implants for temporary use during soft tissue healing after one-stage and two-stage surgeries. It is designed based on the planned final Atlantis® Abutment or Atlantis® Crown Abutment, using the same emergence profile as those abutments to achieve an aesthetic outcome during the soft tissue healing phase.
The proposed Atlantis® Abutments in Titanium for Straumann BLX Implant are compatible with the Straumann BLX Implants. This implant system is available in diameters of 3.5, 3.75, 4.0, 4.5 5.0, 5.5 and 6.5 mm and in lengths of 8, 10, 12, 14, 16, and 18 mm all with identical mating geometry.
The proposed Atlantis® Abutments in Titanium for Neodent GM Implant are compatible with the Neodent GM Implants. This implant system is available in diameters of 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, and 7.0 mm and in lengths of 7, 8, 9, 10, 11, 11.5, 13, 15, 16, 17 and 18 mm, all with identical mating geometry.
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(84 days)
DESS® Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with DESS® Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.
The purpose of this submission is to add abutments to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K242340 and K240208. The subject device abutment designs include Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), and abutment screws.
Pre-Milled Blank Abutments are designed for custom abutment fabrication by a CAD-CAM process. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. The Pre-Milled Blank Abutments have a maximum (before milling) diameter of 10 mm or 14 mm and a solid cylindrical design with an engaging or non-engaging implant connection. They are available in versions with a straight screw channel and with an angled screw channel for esthetic considerations. The Pre-Milled Blank Abutments are manufactured from titanium alloy (Ti 6Al-4V).
The design parameters for the CAD-CAM fabrication of a custom abutment from the Pre-Milled Blank Abutment are:
- Minimum wall thickness – 0.45 mm
- Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
- Minimum gingival height – 0.5 mm
- Maximum gingival height – 6.0 mm
- Pre-Milled Blanks are for straight abutments only
Multi-Unit Abutments: Straight and Angled are designed for attachment of multi-unit screw-retained restorations and are provided in three (3) designs, straight (0°), angled 17°, and angled 30°. The designs of the subject Multi-Unit Abutments are similar to the designs of Multi-Unit Abutments cleared in K242340 and K240208. All Multi-Unit Abutments are manufactured from titanium alloy (Ti-6Al-4V).
The subject device straight Multi-Unit Abutments have a non-engaging, threaded design that attaches directly to the implant. The subject device straight (0°) Multi-Unit Abutments are included in this submission are similar in design to straight Multi-Unit Abutments cleared in K242340, K230143, and K222288. Subject device straight Multi-Unit Abutments are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height ranging from 1 mm to 5.5 mm.
The subject device angled Multi-Unit Abutments are provided only in an engaging design that requires an abutment screw. The subject device Multi-Unit Abutments angled 17° and 30° are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height ranging from 2.5 to 4.5 mm.
Select straight and angled Multi-Unit Abutments have an added coating of zirconium nitride (ZrN). This coating is identical to the ZrN coating used on abutments with ZrN cleared in K242340.
DESS® Dental Smart Solutions Screws are designed to attach the abutment to the implant or the prosthesis to the abutment. There are a total of seventeen (17) subject device screws compatible with the subject device components or previously cleared components. The new screws have designs that are similar to those of screws cleared in K242340 and K240208. Screws are made of titanium alloy (Ti-6Al-4V). Select subject device screws are available with DLC (Diamond-like Carbon) coating and are identical to that used on screws cleared in K240208.
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(173 days)
Bonafix Implant Abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
All digitally designed superstructures, and/or hybrid crowns for use with Titanium Base are to be sent to a Bonafix validated milling center for manufacture.
Bonafix Abutment Solutions are a dental implant abutments system that includes three abutment design types (Temporary, Straight Ti-Base and Multi-Unit), that can be used to support single-unit or multi-unit prosthetic restorations. These abutments incorporating interface features compatible with sixteen (16) endosseous dental implant system platforms (Eight (8) designs from five (5) manufactures). The subject device abutments platform diameters range from 3.5mm to 6.3mm, and the corresponding compatible implant body diameters also range from 3.5 mm to 6.3mm. The system also includes corresponding abutment screws.
Temporary Abutments are manufactured from Titanium Grade 5 and consist of a coronal section, a platform and a connection part. The abutments are provided non-sterile with instructions for end user sterilization. The Temporary Abutments are seated in the implant with a prosthetic screw which is also manufactured from Titanium Grade 5. The prosthetic screw is delivered with the abutment. Angular correction of temporary abutments and placement of implant bodies at an angle is not allowed, they must be used parallel to the direction of occlusal loading forces. Temporary Abutments can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Modifications can be made by the end-user only in the minimum post height. Minimum post height – 4.0 mm. Temporary Abutments have a maximum duration of usage of 180 days.
The Bonafix TiBase abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The superstructure are fabricated using a CAD/CAM process in Zirconia. The apical end is prefabricated to fit the compatible implant platform, as shown above, and is available with implant connections for crowns (with socket) or bridges (without socket). Angular correction of abutments and placement of implant bodies at an angle is not allowed, they must be used parallel to the direction of occlusal loading forces. Each abutment is provided with a screw designed to fit the compatible implant. The design parameters for the fabrication of the zirconia superstructure, which are already locked in the CAD/CAM software, are as follows: Minimum wall thickness – 0.45 mm, Minimum abutment post height – 4.0 mm, Maximum abutment post height – 6.5mm, Maximum gingival height – 5.0 mm, Minimum gingival height – 0.7 mm, Angulation – 0°. All digitally designed superstructures, and/or hybrid crowns for use with Bonafix TiBase abutments are to be sent to a Zentek validated milling center for manufacture. All superstructures are to be manufactured from zirconia conforming to ISO 13356. The required cement for bonding the zirconia superstructure to the Bonafix TiBase abutments to create the final two-piece abutment is G-CEM LinkAce™ cleared in K120243. Bonafix Ti-Base Abutments are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) with the superstructure made of zirconia conforming to ISO 13356 Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).
The Multi-unit abutments are screw-attached to the implant to restore fully or partially edentulous arches. Their use is not intended for single-unit crowns. They are designed with various gingival heights (1.5, 2.5 and 3.5mm) and can be screwed directly to a compatible implant. They use a titanium Multi-unit sleeve, which is cemented to the prosthesis. Together with a titanium prosthetic screw, the prosthesis is ready to be screwed onto the Multi-unit abutment, which in turn is screwed onto the implant, thus completing the restoration. This multi-unit abutments are not intended to provide angle or divergence correction. For all system, are manufactured from Titanium Grade 5. Multi-unit sleeve can only be modified in the post height and that the minimum post height is 4mm from gingival collar.
The Prosthetic screw is used to seat all abutments for the system, included the temporary abutments and ti-bases, to the dental implant. They are provided along the prosthetic components, but they are also provided as standalone screws. The Abutment screws are manufactured from titanium alloy conforming to ASTM F136.
All system abutments are provided non-sterile with instructions for end user steam sterilization. The subject devices are provided non-sterile and required to be sterilized. All Bonafix TiBase abutments are packaged into PET bag.
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(200 days)
Zirconia Implants:
The Neodent Implant System is intended to be surgically placed in the bone of upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusion loading. Multiple teeth applications can be rigidly splinted. The implants with length of 5 mm (short implants) may be used only with two-stage surgical procedures. The recommended healing time before loading is between 10 to 12 weeks.
Zi Transmucosal Cover Screw and Healing:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.
Zi Transmucosal Provisional Coping:
The Neodent Implant System is intended for surgical procedures in maxilla or mandible, providing support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single- or multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Zi Transmucosal Abutment Replacement Screw:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Zi Transmucosal Universal Base:
The Universal Ceramic Base Zi Transmucosal 5.0 is an abutment placed over Neodent Zi Transmucosal 5.0 Ceramic Implant System in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement or screw-retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
Zirconia Base for Bridge:
The Zirconia Base for Bridge is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations. It may be used for cement or screw-retained multi-unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
Zirconia Base C:
The Zirconia Base C is an abutment placed over Neodent Zirconia Implants in order to provide support for customized prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are screw- or cement-retained in esthetic areas over implants installed in the maxilla or mandible. All copings and/or crowns digitally designed for use with the Titanium Base C are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
This premarket notification includes new ceramic devices into Neodent Implant System, which are compatible with Zirconia Implant System. The Zirconia Implants and Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System – Zirconia Implant System, according to predicate devices described above. This submission intends to expand the portfolio with new solutions and diameter, in order to provide more treatment options to the customers.
The Zirconia Implants are manufactured in Zirconia Y-TZP and are available in Bone Level (BL) or Tissue Level (TL or Transmucosal) configurations. The Zirconia Implants (BL) are available in a diameter of 5.0 mm and lengths in a range of 8 to 13 mm. The Zi Transmucosal Implants (TL) are available in a diameter of 5.0 mm and lengths in a range of 5 to 11.5 mm.
The Zi Transmucosal Healing and Cover Screw are temporary abutments manufactured in PEEK and used during the healing phase. They are compatible with the Zi Transmucosal Implants Ø5.0. The Zi Transmucosal Healing Abutment is available in the heights of 2 and 3.5mm.
The Zi Transmucosal Provisional Coping is a temporary abutment made of polycarbonate (PC) and has a double function: used for molding procedures or production of provisional restoration.
The Zi Transmucosal Abutment Replacement Screw is a prosthetic component manufactured in titanium alloy and used to fix the fix the Zi Transmucosal Base to the Zi Transmucosal Implant.
The Zi Transmucosal Universal Base is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zi Transmucosal Implant (TL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 0.3, 1.0 and 1.5 mm. The top-half prosthetic structure to be used with Zi Transmucosal Universal Base must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions:
Material: IPS e.max CAD HT, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm, Maximum angulation: 30°
Material: IPS e.max CAD LT, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm
Material: N!ce, Associated Material 510(k): K171773, Minimum wall thickness: 1.0 mm
Material: IVOCLAR Multilink cement, Associated Material 510(k): K130436, Minimum wall thickness: N/A
Material: Zirconia N!ce® LT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® HT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® XT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: PMMA N!ce, Associated Material 510(k): K071548, Minimum wall thickness: 0.7 mm
Material: Panavia—Kuraray Cement, Associated Material 510(k): K150704, Minimum wall thickness: N/A, Maximum angulation: N/A
The Zi Base for Bridge is a two-piece abutment of base and top-half prosthetic structure to provide support for customized multi-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 1.5, 2.5 and 3.5 mm. The top-half prosthetic structure to be used with Zi Base for Bridge must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions:
Material: Zirconia N!ce® LT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm, Maximum angulation: 30°
Material: Zirconia N!ce® HT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® XT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: PMMA N!ce, Associated Material 510(k): K071548, Minimum wall thickness: 0.7 mm
Material: Panavia—Kuraray Cement, Associated Material 510(k): K150704, Minimum wall thickness: N/A, Maximum angulation: N/A
The Zi Base C is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 1.5, 2.5, 3.5 and 4.5 mm. The top-half prosthetic structure to be used with Zi Base C must be designed and milled in a Sirona InLab Validated Workflow, using the following restoration materials and dimensions:
Material: IPS e.max CAD, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm, Maximum angulation: 20°
Material: IVOCLAR Multilink cement, Associated Material 510(k): K130436, Minimum wall thickness: N/A, Maximum angulation: N/A
All these abutments have an internal connection with the implants (ZiLock) and the prosthetic platform is identical for all subject devices described in this submission. They are intended for single use and provided sterile via Ethylene Oxide method, along with undergoing moist heat sterilization after end-user customization.
The provided FDA 510(k) clearance letter and its associated summary for the Neodent Implant System - Zirconia Implant System contain extensive information about the device, its intended use, and comparisons to predicate devices. However, it does not include specific acceptance criteria with numerical thresholds directly stated within the tables, nor does it detail a study that directly proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or image quality assessments.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various tests, implying that if the new device performs similarly to or better than previously cleared devices, it meets the necessary standards. The performance testing section describes the types of tests conducted (e.g., dynamic fatigue, torsion, insertion, pull-out, and software validation), but it does not present clear quantitative acceptance criteria or the specific performance results in a comparative table format.
Therefore, many of the requested fields cannot be directly extracted from the provided text as they pertain more to the performance evaluation of AI/software in interpreting medical images, which is not the primary focus of this dental implant submission.
Here's an attempt to answer the questions based on the available information, noting where information is not explicitly provided in the document:
Acceptance Criteria and Device Performance Study for Neodent Implant System - Zirconia Implant System
The FDA 510(k) summary for the Neodent Implant System - Zirconia Implant System focuses on demonstrating substantial equivalence to predicate devices through a combination of bench testing, software validation, MRI compatibility, biocompatibility, and sterilization validation. It does not present specific quantitative acceptance criteria or performance metrics directly from a comparative study in the way one might expect for an AI/software-based medical device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating that the proposed devices perform at a level substantially equivalent to legally marketed predicate devices under standardized testing conditions.
1. A table of acceptance criteria and the reported device performance
As mentioned, explicit numerical acceptance criteria and reported device performance in a comparative table (e.g., for diagnostic accuracy) are not provided in this 510(k) summary. The summary indicates that tests were conducted according to relevant ISO standards and FDA guidance, and the results demonstrated that the subject devices exhibit a level of performance substantial equivalent to the predicate and reference devices.
Below is a conceptual table based on the types of tests mentioned, noting that specific numerical acceptance criteria and performance data are not detailed in the provided text.
| Acceptance Criteria Category (Implicit) | Standard/Guidance | Reported Device Performance (Summary) |
|---|---|---|
| Dynamic Fatigue Strength | ISO 14801, FDA Guidance (Class II Special Controls) | Demonstrated a level of performance substantial equivalent to predicate and reference devices in identical conditions. |
| Torsion Strength | Not specified | Adequate torsion strength in accordance with recommended IFU installation torque. |
| Insertion Torque | Not specified | Evaluated insertion torque in sawbones material (Bone type I, II, III, IV). (Specific values not given). |
| Implant Surface Area & Pull-Out Strength | Not specified | Greater surface area compared to reference devices; higher resistance values in Pull Out Test. |
| Software Validation (Sirona Digital Workflow) | Not specified | Accuracy requirement was met; critical design parameters (min wall thickness, max angulation) respected and monitored. |
| MRI Compatibility | K182620, FDA Guidance | MR conditional labeling from K182620 is applicable; safe for scanning under previously established parameters. |
| Biocompatibility | ISO 10993-1, ISO 10993-18, ISO 10993-5, FDA Guidance | Subject devices are equivalent in material and manufacturing processes to predicates; no new issues raised; no additional testing required. |
| Sterilization Validation (Ethylene Oxide) | ISO 11135:2014 | Validated to a Sterility Assurance Level (SAL) of 1x10⁻⁶; residuals below max allowable limits per ISO 10993-7. |
| Sterilization Validation (Moist Heat) | ISO 17665-1 | Validated using parameters described in IFU. |
| Endotoxin Test | ANSI/AAMI ST72:2011, ISO 11737-3, US Pharmacopeia chapter 85 | Results <0.05 EU/device. |
| Shelf Life | Not specified | Determined to be 5 years; packaging identical to predicates. |
2. Sample size used for the test set and the data provenance
The document details various bench tests (dynamic fatigue, torsion, insertion, pull-out) and validation studies (software, MRI, biocompatibility, sterilization, endotoxin, shelf-life). However, specific numerical sample sizes ("n=") for these individual tests are not provided in the summary. For example, for dynamic fatigue testing, it states "the results demonstrated that...". It doesn't specify how many implants or setups were tested.
- Data Provenance (Country of Origin): The submitter is JJGC Indústria e Comércio de Materiais Dentários S.A. (dba Neodent) based in Curitiba, Paraná, Brazil. The tests are generally conducted to international ISO standards and FDA guidance, but the location where the tests were performed is not explicitly stated for each test beyond the company's Brazilian location.
- Retrospective or Prospective: Not applicable in the context of bench testing and validation studies as described. These are laboratory-based tests rather than clinical studies on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the context of this 510(k) submission. The device is a dental implant system (hardware), not an AI/software device that interprets medical images requiring expert-established ground truth for a test set. The validation processes involve standardized engineering and biological tests as opposed to expert review of clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. As explained above, the submission pertains to a hardware device, not an AI/software system requiring human adjudication for ground truth establishment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. This type of study is relevant for AI-assisted diagnostic tools, not for dental implant hardware.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This concept is specific to AI/software performance, not a physical dental implant system. The "software validation" mentioned is for the compatibility of milling units (CAD/CAM workflow), ensuring design parameters are respected, not for an AI algorithm interpreting dental images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench tests, the "ground truth" is defined by compliance with established engineering standards (e.g., ISO 14801 for dynamic fatigue) and specifications (e.g., material properties, dimensions). For biological safety, it's compliance with ISO 10993. For the CAD/CAM software, it's the accurate adherence to design parameters. This isn't "ground truth" in the diagnostic sense, but rather adherence to predefined engineering and biocompatibility specifications.
- Clinical Literature Review: A clinical literature review was conducted to support the safety of Zi Transmucosal Implant less than 7mm of length, referencing animal studies and histomorphometry evaluation. This aligns with outcomes data or pathological/histological evidence from preclinical studies, suggesting "similar osseointegration outcomes" and "ability to promote bone formation around them in a manner equivalent to titanium implants."
8. The sample size for the training set
This information is not applicable and not provided. This concept is specific to machine learning/AI models, which are not the subject of this 510(k) submission.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As above, this is relevant for AI/ML training data, not for a physical dental implant system.
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(87 days)
Sherlock abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
All digitally designed CAD/CAM customizations for Sherlock abutments are to be sent to an Open Implants-validated milling center for manufacture.
Sherlock abutments are compatible with the implant systems listed in the Compatibility Table:
Compatibility Table
| Compatible Implant Systems | Implant Body Diameter (mm) | Implant Platform Diameter (mm) |
|---|---|---|
| Neodent Helix GM®, Drive GM®, Titamax GM® | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | 3.0 |
Sherlock is a dental implant abutment system that is being expanded to include a new compatible implant system, Neodent GM®. The Subject device implant platform diameter is 3.0 mm, and the corresponding compatible implant body diameters range from 3.5 mm to 7.0 mm.
The abutment designs are Titanium Base, Titanium Blank, Straight Multi-Unit, Multi-Unit Angled 17°, and Multi-Unit Angled 30° Abutments. These abutment designs were previously cleared in the sponsor's K220482 Predicate device and K212664 Reference device submissions. All abutment designs are provided with corresponding abutment screws.
The Subject device Titanium Base abutments are intended to be used as a two-piece abutment composed of the base bottom-portion (prefabricated titanium base component) with a cemented/bonded CAD-CAM fabricated zirconia top-portion (superstructure) where the final two-piece abutment (base component and cemented superstructure) is the finished device used for the prosthetic restoration. Each patient-specific zirconia superstructure is individually prescribed by the clinician and manufactured by an authorized milling center.
All Subject device prefabricated titanium base components are provided in a straight design with no angulation in the titanium base post. They are provided with either an indexed/engaging implant connection for crowns or a non-engaging/nonindexed implant connections for bridges. The standard prefabricated titanium base components are provided in gingival heights ranging from 0.8 mm to 3.0 mm and abutment post lengths of 8 mm or 10 mm. The ASC prefabricated titanium base components are provided in gingival heights ranging 0.8 mm to 2.5 mm and abutment post length of 8 mm. Additional gingival height may be provided for both abutment designs in the zirconia superstructure. ASC prefabricated titanium base components are provided with a cutout in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. Standard prefabricated titanium base components and ASC prefabricated titanium base components posts may be reduced to 4 mm to accommodate individual patient occlusion. The zirconia mesostructure may contain an angled post within the established design parameters.
The overall design parameters for the two-part Standard and ASC CAD/CAM prefabricated titanium base components with zirconia mesostructure are:
- Minimum Zirconia Wall Thickness – 0.5 mm
- Minimum Post Height for single-unit abutment* – 4.0 mm
- Minimum Overall Gingival Height – 0.8 mm (titanium base plus zirconia)
- Maximum Overall Gingival Height – 5 mm
- Maximum Correction Angle – 30°
The required cement for bonding the zirconia superstructure to the Subject device Titanium Bases to create the final two-piece abutment is Kuraray Noritake Dental PANAVIA™ V5 cleared in K150704.
Titanium Blank abutments, sometimes referred to as "Pre-mill" or "Ti-Blank" abutments are one-part abutments intended for use in a CAD/CAM workflow. Each Subject device Titanium Blank implant abutment has a pre-manufactured indexed implant connection interface with a cylindrical customization section and a milling retention geometry section. The retention geometry holds the component in a milling machine fixture while the patient-specific portion above the implant interface is milled in a dental milling machine. All patient-specific Titanium Blank abutment fabrication is by prescription on the order of the clinician.
The overall design parameters for the Titanium Blank customized abutments are:
- Minimum Wall Thickness – 0.75 mm
- Minimum Post Height for single-unit abutment* – 4.0 mm
- Minimum Overall Gingival Height – 0.8 mm
- Maximum Overall Gingival Height – 5 mm
- Maximum Correction Angle – 30°
All digitally designed zirconia mesostructures for use with the Subject device titanium base abutments and digitally designed Subject device titanium blank abutments will be fabricated at an Open Implants validated milling center under FDA quality system regulations.
Multi-Unit Abutments (MUAs) are intended for use with multi-unit restorations. They are considered two-part abutments. The base portion of the MUA is connected directly to the implant either with an integral screw (straight MUA) or with a separate multi-unit abutment screw (angulated abutments). Straight MUAs have a non-indexed connection with the dental implant. The angulated MUAs have an indexed connection with the dental implant. The second part of the MUA is a mating coping which is retained with a prosthetic screw. Multi-Unit Abutments are available in Straight, 17° Angulated and 30° Angulated configurations. The coping and prosthetic screw is compatible with each MUA design/configuration.
All Subject device abutments and corresponding abutment screws are pre-manufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and are provided non-sterile to the user. The mesostructure/copings for Titanium base abutments are fabricated from zirconia conforming to ISO 13356, Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).
The provided FDA 510(k) Clearance Letter for Sherlock Dental Implant Abutment does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This document describes the device's indications for use, its substantial equivalence to predicate devices, and the non-clinical data reviewed by the FDA for clearance. However, it does not detail specific acceptance criteria or an associated study demonstrating compliance with those criteria.
The "Performance Data" section lists several types of non-clinical data submitted, such as static and fatigue testing according to ISO 14801, a reverse engineering study, biocompatibility testing, cleaning and sterilization validation, and an MRI review. These are the studies performed to support the substantial equivalence claim, but the FDA letter does not specify quantitative acceptance criteria for these tests nor does it report specific performance outcomes that directly address such criteria.
Therefore, I cannot populate the requested table or provide details for points 1-9 based solely on the provided text. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a performance study against predefined acceptance criteria.
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(271 days)
MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name |
|---|---|---|
| Straumann Bone Level (CrossFit® Morse Taper) | 2.9 | SC |
| 3.3 | NC | |
| 4.1, 4.8 | RC | |
| Straumann® Tissue Level (CrossFit® Connection) | 3.3, 4.1, 4.8 | RN |
| 4.8 | WN | |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB |
| 5.0, 5.5, 6.5 | WB | |
| Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) |
All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.
MIST IC from Imagine Milling Technologies, LLC is a line of Ti-base and machinable blank abutments to interface with compatible dental implants from four (4) manufacturers, and a total of eight (8) implant-abutment interface compatibilities. The subject device prosthetic platform diameters range from 3.8 mm to 6.9 mm. All stock subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. The subject device MIST IC L-LINK abutments have a TiN coating achieved through a physical vapor deposition (PVD) process that is identical to the process used for TiN coating of Imagine Milling Technologies, LLC devices cleared in K222368. The PVD cathodic arc evaporation process is a high current, low voltage process in which material evaporated from the cathode (Ti) is ionized, transported through the vacuum chamber with reactive gas (N2) and deposited as a non-porous, thin film on the titanium substrate. Each abutment is supplied with the non-sterile abutment screw designed for attachment to the corresponding compatible OEM implant.
All patient-specific abutment fabrication for all MIST IC abutments is by prescription on the order of the clinician. All MIST IC abutments are intended to be milled at an Imagine Milling Technologies, LLC validated milling center under FDA quality system regulations.
MIST IC L-LINK abutments are two-piece abutments to be used as a base when fabricating a CAD-CAM customized restoration where the superstructure produced will compose the second part of the two-piece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. They are provided with engaging and non-engaging connections.
The L-LINK abutments and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory, or separately for the clinician to bond together chairside using the cement required in the labeling (RelyX RMGIP bonding cement, cleared in K022476).
The design parameters for L-LINK patient-specific abutments are:
- Minimum wall thickness – 0.5 mm
- Minimum cementable post height for single-unit restoration – 4.0 (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
- Minimum gingival height – 0.5 mm
- Maximum gingival height (for all except Straumann BLX L-Link) – 5.0 mm
- Maximum gingival height (for Straumann BLX L-LINK) – 6.0 mm
- Maximum angle – 20°
All zirconia copings (superstructures) for use with the subject device MIST IC L-LINK abutments will conform to ISO 13356.
MIST IC PREFIT abutments are cylindrical abutments designed for patient-specific abutment fabrication by a CAD-CAM process and machined into a one-piece, all titanium abutment. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. MIST IC PREFIT abutments have an engaging connection.
The design parameters for PREFIT patient-specific abutments are:
- Minimum wall thickness – 0.5 mm
- Minimum cementable post height for single-unit restoration – 4.0 (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
- Minimum gingival height – 0.5 mm
- Maximum gingival height (for all except Straumann BLX PREFIT) – 5.0 mm
- Maximum gingival height (for Straumann BLX PREFIT) – 6.0 mm
- Maximum angle – 30°
The provided document is a 510(k) clearance letter for a dental device, specifically dental implant abutments. It details the device's administrative information, predicate devices, indications for use, subject device description, and performance data used to demonstrate substantial equivalence.
However, the document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm. The performance data section refers to non-clinical analyses, such as MR compatibility, sterilization validation, biocompatibility, mechanical properties testing, reverse engineering, and static/dynamic compression-bending testing conforming to ISO 14801. These are standard tests for mechanical dental devices, not AI/ML performance evaluation.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI device meets them based on the given text. The device described, "Mist IC," is a physical dental implant abutment, not an artificial intelligence/machine learning (AI/ML) powered medical device.
To directly answer your prompt based on the provided text, the following information is missing or not applicable:
- A table of acceptance criteria and the reported device performance: Not applicable. The document describes mechanical and material performance testing for a physical device, not AI/ML performance metrics like sensitivity, specificity, or AUC against defined acceptance criteria for an AI algorithm.
- Sample sizes used for the test set and the data provenance: Not applicable. There is no AI/ML test set. The document refers to testing of physical components (OEM implants, abutments, screws, subject device constructs).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No AI/ML ground truth establishment.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be the physical properties and mechanical integrity verified by engineering standards (e.g., ISO 14801).
- The sample size for the training set: Not applicable. No AI/ML training set mentioned.
- How the ground truth for the training set was established: Not applicable. No AI/ML training set mentioned.
The document focuses solely on the substantial equivalence of the "Mist IC" dental implant abutments to legally marketed predicate devices based on design, materials, manufacturing, and conventional mechanical/material performance testing.
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(197 days)
Dynamic TiBase abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
Compatible Implant Systems:
| Compatible Implant System (Connection) | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Osstem® TS Hiossen® ET (Internal Taper) | 3.5 | Mini |
| 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular | |
| Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM |
| Nobel Active (Conical Connection) | 3.5 | NP |
| 4.3, 5.0 | RP | |
| 5.5 | WP | |
| Straumann Bone Level (CrossFit® Morse Taper) | 3.3 | NC |
| 4.1, 4.8 | RC | |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB |
| 5.0, 5.5, 6.5 | WB |
All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Talladium Medical validated milling center for manufacture.
Dynamic TiBase abutments are two-piece abutments composed of a CAD-CAM fabricated zirconia superstructure and a prefabricated titanium base component where the final two-piece abutment (base and cemented superstructure) is the finished device used for the prosthetic restoration. All subject device bases are made of titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 and ASTM F136. The Dynamic TiBase abutments are provided in engaging and non-engaging designs for single-unit and multi-unit restorations, respectively.
For each of the compatible OEM implant lines, the prefabricated titanium base components are provided with a gingival height (in the titanium base) ranging from 0.3 mm to 4 mm, and a platform diameter ranging from 4.30 mm to 5.50 mm. Angulation and additional gingival height may be provided in the zirconia superstructure. All Dynamic TiBase prefabricated titanium base components have a post with a cut-out to accommodate a restoration with an angled channel for screw access when clinically necessary. The post height of the prefabricated titanium base component ranges from 3.8 mm to 5.40 mm, and from 2.3 mm to 3.8 mm (cut-out height). The cementable post height of the final patient-matched abutment design, measured above the total combined gingival collar, shall be no less than 4 mm.
All zirconia superstructures (copings) used to complete the final two-piece subject device Dynamic TiBase abutment will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.
The design parameters for the CAD-CAM zirconia superstructure for the Dynamic TiBase vary slightly among the compatible OEM implants. The design parameters for the CAD-CAM zirconia superstructure are summarized in the following table:
| Implant Compatibility (1) | Minimum Wall Thickness, mm | Maximum Gingival Height, mm | Minimum Gingival Height (2), mm | Maximum Angulation |
|---|---|---|---|---|
| Osstem® TS Hiossen® ET (Internal Taper) | 0.32 | 5.18 | 1.2 | 25º |
| Neodent GM (Morse taper) | 0.32 | 5.20 | 1.2 | 30º |
| Nobel Active (Conical Connection) | 0.35 | 6.20 | 0.30 | 0º |
| Straumann Bone Level (CrossFit® Morse Taper) | 0.32 | 5.18 | 1.1 | 30º |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 0.32 | 5.34 | 1.5 | 30º |
(1) for the compatible sizes shown in Table 1
(2) minimum gingival height in the titanium base, not the zirconia superstructure
The required cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is Nova Resin Cement cleared in K213609.
Also, the subject of this submission are seven (7) abutment screws for use with the subject abutments.
This FDA 510(k) clearance letter pertains to a dental implant abutment — the Dynamic TiBase — not an AI-powered diagnostic device or software. Therefore, the information typically requested about acceptance criteria and study designs for validating AI/ML-based medical devices (such as sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable to this document.
The "performance data" section in this 510(k) summary refers to traditional engineering and biocompatibility testing for a physical medical device, not performance metrics for an algorithm.
Here's how to interpret the provided document in the context of "acceptance criteria" and "proof":
Acceptance Criteria and Reported Device Performance (as inferred for a physical device):
For a physical device like the Dynamic TiBase, the "acceptance criteria" are generally met through demonstrating substantial equivalence to a previously cleared predicate device. This involves validating material properties, manufacturing processes, functional performance (e.g., mechanical strength, compatibility), and biocompatibility.
The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to demonstrate substantial equivalence.
| Acceptance Criterion (Inferred for a Dental Abutment) | Reported Device Performance / Proof |
|---|---|
| Biocompatibility (Device materials are safe for biological contact) | Referenced from K232151 (provided in K212108): Biocompatibility testing according to ISO 10993-5 (cytotoxicity) for abutment materials ASTM F136 (titanium alloy) and ISO 13356 (zirconia). This indicates the materials did not show cytotoxic effects when tested according to the standard. |
| Mechanical Performance/Strength (Abutment can withstand oral forces without failure) | Provided in this submission: Mechanical testing conducted according to ISO 14801 to support the performance of the subject device abutments in conjunction with the compatible OEM implants. This standard specifically evaluates the fatigue strength of endosseous dental implants. The successful completion of this testing, validated against the predicate device, implies the device meets required load-bearing capacities. |
| MRI Safety (Device does not pose undue risk in MRI environment) | Provided in this submission: Non-clinical worst-case MRI review to evaluate subject device components in the MR environment using scientific rationale and published literature. This included addressing magnetically induced displacement force and torque parameters as per FDA guidance. The review concluded that the device is safe for MRI under specified conditions. |
| Sterilization Efficacy (Device supplied non-sterile can be effectively sterilized by user) | Referenced from K232151 (provided in K212108): Moist heat sterilization validated to a sterility assurance level (SAL) of 10-6 by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2. This demonstrates that the specified sterilization method for end-users achieves the required sterility. |
| Dimensional Compatibility & Fit (Device correctly interfaces with specified implants) | Provided in this submission: Reverse engineering dimensional analysis (of OEM implant bodies, OEM abutments, and OEM abutment screws) to demonstrate that the subject device abutments are compatible with listed OEM Implant Systems (Osstem® TS/ Hiossen® ET, Neodent GM, NobelActive, Straumann Bone Level, and Straumann BLX Implant Systems). This confirms the physical design correctly matches the intended implant systems. |
| Material Conformance (Materials meet specified standards) | Materials confirmed to conform to: Ti-6Al-4V (ASTM F136, ISO 5832-3) for titanium components; Zirconia (ISO 13356) for superstructure; Nova Resin Cement (cleared in K213609) for bonding. This demonstrates the use of medical-grade, standard-compliant materials. |
| Manufacturing Quality (Device is produced under controlled conditions) | Stated that zirconia superstructures will be made at a Talladium España, SL validated milling center under FDA quality system regulations. This implies adherence to Good Manufacturing Practices (GMP). |
Regarding the specific questions about an AI/ML context:
- A table of acceptance criteria and the reported device performance: Provided above, adapted for a physical medical device.
- Sample size used for the test set and the data provenance: Not applicable. The "test set" for this physical device refers to the number of physical abutment samples or material samples subjected to mechanical, biocompatibility, and MRI testing. The document does not specify exact sample numbers for these engineering tests, only the standards used (e.g., ISO 14801 typically specifies minimum sample sizes). Data provenance is "non-clinical data" generated from laboratory testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a dental abutment's performance is established by engineering standards, material specifications, and physical testing, not by expert human interpretation of images or clinical outcomes in the same way as an AI diagnostic.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is a concept used in evaluating human reader performance in AI studies.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI-assisted diagnostic devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to an AI algorithm's performance.
- The type of ground truth used: For a physical device, "ground truth" is defined by adherence to established engineering standards (e.g., ISO 14801 for mechanical strength), material properties, and biocompatibility standards. "Reverse engineering dimensional analysis" served as a form of "ground truth" for compatibility. No pathology or outcomes data was used for this premarket notification.
- The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) clearance is for a physical medical device (dental abutment), and the "performance data" section details the engineering and material testing conducted to demonstrate its safety and effectiveness, primarily through substantial equivalence to previously cleared devices. It does not involve AI/ML validation methodologies.
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(88 days)
Custom Abutment AS Ti:
The Custom Abutment with Angled Screw Channel is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments with Angled Screw Channel are indicated for screw-retained single restorations or cemented retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Angled Screw Channel are intended to be sent to Straumann for manufacturing at a validated milling center.
ASC Screw:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
This premarket notification includes new digital abutments to the Neodent Implant System (GM, NGM and HS prosthetic interfaces). The abutments proposed on this submission are identical to devices already cleared in previous submissions of Neodent Implant System, according to predicate devices described above, being the only difference between them the introduction of a new angled channel solution. This submission intends to expand the portfolio of Neodent Implant System. The Custom Abutments AS Ti are composed of a unique body with two different regions: the upper region, which is the customizable portion, and the end region presents the prosthetic interface that fits with the implant, which does not allow customization. They must be sent to a Straumann Validated Milling
This document describes the Neodent Implant System - Custom Abutments and its FDA 510(k) clearance (K250614). The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results with specific acceptance criteria and performance metrics for a novel AI/software device.
Based on the provided text, the device is a physical medical device (dental implant abutment) and not an AI/software device. Therefore, the questions related to AI/software performance studies, such as sample size for test sets, expert adjudication, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.
The "Performance Testing" section primarily describes bench testing (dynamic fatigue and torsion tests), biocompatibility testing, and sterilization validation, which are standard for physical medical devices.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the format typically seen for performance metrics of a diagnostic device. Instead, it describes general compliance with standards and the determination of "not a new worst case" for dynamic fatigue.
| Acceptance Criterion (Inferred from testing) | Reported Device Performance |
|---|---|
| Dynamic Fatigue Testing (ISO 14801 compliant, FDA Guidance) | Subject devices are not a new worst case compared to predicate devices. (No specific values reported in this document). |
| Torsion Testing | Results prove adequate torsion strength in accordance with recommended installation torque. (No specific values reported). |
| Biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-18 compliant) | Subject devices are equivalent in material and manufacturing processes to predicate devices; no new issues raised, no additional testing required. |
| Sterilization Validation (ISO 17665-1 compliant) | Sterilization method (moist heat, SAL of 1x10-6) was validated and is identical to predicate devices. |
| MRI Compatibility | MR conditional labeling from predicate (K182620) is applicable to subject devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Bench Testing (Dynamic Fatigue and Torsion): Not
explicitly stated. The document mentions "a worst case analysis determined that the subject devices are not a new worst case compared to those devices tested for the primary predicate." This implies that testing was performed on a sufficient number of samples to make this determination, likely following the requirements of ISO 14801. - Data Provenance: Not explicitly stated, but these are typically laboratory-based bench tests performed by the manufacturer or a contracted testing facility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a physical device, and the testing involves objective measurements (e.g., force, torque, material properties) rather than expert interpretation of data for ground truth establishment.
4. Adjudication Method for the Test Set
- Not Applicable. As above, the tests are objective physical measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- Not Applicable. This is a physical device, not an AI-assisted diagnostic or decision support system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is a physical device. While it involves digital design using CAD/CAM software, the 'device' itself is the physical abutment, and its performance is evaluated through physical and material tests, not software algorithm performance.
7. The Type of Ground Truth Used
- Physical/Material Standards and Engineering Specifications. For dynamic fatigue and torsion tests, the "ground truth" or acceptance criteria are derived from established engineering principles, material properties (ASTM F136 for titanium alloy), and international standards (ISO 14801). For biocompatibility, it's compliance with ISO 10993 series.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical device; there is no "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, no training set for an AI/ML model for this physical device.
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(80 days)
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with DESS Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine, and associated tooling and accessories.
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K221301 and K240982 to allow additional options of zirconia material, scanners, CAM software, and milling machines to the digital dentistry workflow. The subject devices are to be sent to Terrats Medical validated milling centers for manufacture, or to be designed and manufactured via a digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine, and associated tooling and accessories. There are no changes to the abutment design, implant compatibilities, or design parameters. All part numbers have been cleared for manufacturing via a validated milling center and digital dentistry workflows (also referred to as point of care) under K221301 and K240982.
The subject device DESS Dental Smart Solutions abutments provide a range of prosthetic solutions for dental implant restoration. DESS abutments are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile, and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.
Subject device Base Abutments are designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.
All patient-specific custom abutment fabrication for Base Abutments and Pre-milled (Blank) Abutments is by prescription on the order of the clinician. The subject device Pre-milled (Blank) Abutments and all zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base, ELLIPTIBase, and DESS C-Base will be manufactured using a validated milling center or a digital dentistry workflow. A validated milling center will be under FDA quality system regulations. The digital dentistry workflow scans files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine and associated tooling and accessories.
The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
The provided 510(k) summary for DESS Dental Smart Solutions focuses on demonstrating substantial equivalence to predicate devices for dental implant abutments. It primarily addresses the expansion of compatible materials, scanners, CAM software, and milling machines within an existing digital dentistry workflow. The document does not describe an AI/ML-based device that would typically have acceptance criteria related to diagnostic performance.
Therefore, many of the requested items related to AI/ML device performance (like acceptance criteria for diagnostic metrics, sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this submission.
The acceptance criteria and supporting "study" (non-clinical data) for this device are related to its mechanical performance, biocompatibility, and integration within the digital workflow, demonstrating that the expanded components maintain the safety and effectiveness of the previously cleared predicate devices.
Here's a breakdown based on the information provided and the non-applicability of AI/ML-specific questions:
1. A table of acceptance criteria and the reported device performance
Since this is not an AI/ML diagnostic device, the acceptance criteria are not in terms of traditional diagnostic metrics (sensitivity, specificity, AUC). Instead, they are related to material properties, mechanical integrity, and the digital workflow's accuracy.
| Acceptance Criteria Category | Reported Device Performance (Summary from Submission) |
|---|---|
| Mechanical Integrity / Compatibility | - Fatigue testing of OEM implant bodies with patient-specific abutments made at worst-case angled conditions. (Implies successful completion to similar or better standards than predicate.) |
| Biocompatibility | - Biocompatibility testing according to ISO 10993-5 and ISO 10993-12. (Implies successful demonstration of biocompatibility.) |
| Sterilization | - Sterilization validation according to ISO 17665-1, ISO 17665-2, and ISO 14937. (Implies successful validation for sterilization.) |
| CAD Design Restrictions | - Software verification included testing of restrictions that prevent design of components outside of the stated design parameters. - Abutment design library validated to demonstrate established design limitations are locked and cannot be modified by the user. (Implies successful implementation and verification of design constraints.) |
| CAM Restriction Zones / Manufacturing Accuracy | - Validation testing of CAM restriction zones conducted, including verification to show avoidance of damage or modifications of the connection geometry, and locking of restriction zones from user editing in CAM software. (Implies successful validation to ensure manufacturing precision and prevent damage.) |
| Material Conformance | - Zirconia materials conform to ISO 6872. - Titanium alloy conforms to ASTM F136. - Co-Cr-Mo alloy conforms to ASTM F15337. (Implies materials meet standards.) |
| Physical Dimensions | - Device encompasses the same range of physical dimensions as the predicate device. (Implies dimensional equivalence.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in terms of a "test set" for diagnostic performance. The validation involved physical testing of components (e.g., fatigue testing) and software verification. The specific number of abutments or digital design instances used for these non-clinical tests is not detailed in this summary.
- Data Provenance: Not applicable in the context of patient data for an AI/ML device. The "data" here refers to engineering and material testing results, likely conducted in controlled lab environments (implied to be in accordance with international standards like ISO and ASTM). The manufacturer is Terrats Medical SL, in Spain, so testing would likely originate from their facilities or contracted labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device relates to engineering specifications and material science.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a diagnostic device involving expert review adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" is based on:
- Engineering Specifications: Defined design parameters (e.g., minimum wall thickness, post height, angulation limits).
- Material Standards: Conformance to international standards such as ASTM F136, ISO 6872.
- Benchmarking/Predicate Equivalence: Performance is assessed against established performance of the predicate devices and OEM implant systems.
- Software Validation Logic: Verification that software correctly enforces design rules and CAD/CAM restrictions.
8. The sample size for the training set
Not applicable. This device does not involve a machine learning training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a machine learning training set.
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